Caprosyn GC-322Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10884521034556), received between Feb 26, 2018 and Jun 26, 2026 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (37 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Break

  ACCORDING TO THE REPORTER, DURING HEMORRHOID PROCEDURE, WHEN SUTURING, THREE SUTURES WERE DAMAGED. ANOTHER SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633553 ↗
• MalfunctionJun 26, 2026Break

  ACCORDING TO THE REPORTER, DURING HEMORRHOID PROCEDURE, WHEN SUTURING, THREE SUTURES WERE DAMAGED. ANOTHER SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633536 ↗
• MalfunctionJun 26, 2026Break

  ACCORDING TO THE REPORTER, DURING HEMORRHOID PROCEDURE, WHEN SUTURING, THREE SUTURES WERE DAMAGED. ANOTHER SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633526 ↗
• MalfunctionApr 17, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER DURING THE HEMORRHOIDECTOMY, THE NEEDLE BENT AND THE NEEDLE DETACHED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906959 ↗
• MalfunctionMar 7, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER DURING THE HEMORRHOIDECTOMY, WHEN CLOSING THE WOUND THE NINE NEEDLES BENT. AFTER THE FIRING IS APPLIED TO THE TISSUE, THE NEEDLES WERE HELD WITH THE NEEDLE HOLDER AND THE THREAD WAS PULLED, THE NEEDLES BECAME MISALIGNED AFTER 3 TO 4 SUTURING. ADDITIONALLY IT WAS NOTED THAT NEEDLES DETACHED. A NEW NEEDLE FROM ANOTHER COMPANY WAS TAKEN OUT AND THE SUTURE WAS ATTACHED TO THE PATIENT CONTINUED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541210 ↗
• MalfunctionMar 7, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER DURING THE HEMORRHOIDECTOMY, WHEN CLOSING THE WOUND THE NINE NEEDLES BENT. AFTER THE FIRING IS APPLIED TO THE TISSUE , THE NEEDLES WERE HELD WITH THE NEEDLE HOLDER AND THE THREAD WAS PULLED, THE NEEDLES BECAME MISALIGNED AFTER 3 TO 4 SUTURING. ADDITIONALLY IT WAS NOTED THAT NEEDLES DETACHED. A NEW NEEDLE FROM ANOTHER COMPANY WAS TAKEN OUT AND THE SUTURE WAS ATTACHED TO THE PATIENT CONTINUED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541208 ↗
• MalfunctionMar 7, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER DURING THE HEMORRHOIDECTOMY, WHEN CLOSING THE WOUND THE NINE NEEDLES BENT.  AFTER THE FIRING IS APPLIED TO THE TISSUE , THE NEEDLES WERE HELD WITH THE NEEDLE HOLDER AND THE THREAD WAS PULLED, THE NEEDLES BECAME MISALIGNED AFTER 3 TO 4 SUTURING. ADDITIONALLY IT WAS NOTED THAT NEEDLES DETACHED. A NEW NEEDLE FROM ANOTHER COMPANY WAS TAKEN OUT AND THE SUTURE WAS ATTACHED TO THE PATIENT CONTINUED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541204 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE HEMORRHOIDECTOMY, WHEN CLOSING THE WOUND, THE NINE NEEDLES BENT. AFTER THE FIRING IS APPLIED TO THE TISSUE, THE NEEDLES WERE HELD WITH THE NEEDLE HOLDER AND THE THREAD WAS PULLED, THE NEEDLES BECAME MISALIGNED AFTER 3 TO 4 SUTURING. ADDITIONALLY, IT WAS NOTED THAT NEEDLES DETACHED. A NEW NEEDLE FROM ANOTHER COMPANY WAS TAKEN OUT, AND THE SUTURE ATTACHED TO THE PATIENT CONTINUED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496765 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE HEMORRHOIDECTOMY, WHEN CLOSING THE WOUND, THE NINE NEEDLES BENT. AFTER THE FIRING IS APPLIED TO THE TISSUE, THE NEEDLES WERE HELD WITH THE NEEDLE HOLDER AND THE THREAD WAS PULLED, THE NEEDLES BECAME MISALIGNED AFTER 3 TO 4 SUTURING. ADDITIONALLY, IT WAS NOTED THAT NEEDLES DETACHED. A NEW NEEDLE FROM ANOTHER COMPANY WAS TAKEN OUT, AND THE SUTURE ATTACHED TO THE PATIENT CONTINUED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496732 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE HEMORRHOIDECTOMY, WHEN CLOSING THE WOUND, THE NINE NEEDLES BENT. AFTER THE FIRING IS APPLIED TO THE TISSUE , THE NEEDLES WERE HELD WITH THE NEEDLE HOLDER AND THE THREAD WAS PULLED, THE NEEDLES BECAME MISALIGNED AFTER 3 TO 4 SUTURING. ADDITIONALLY, IT WAS NOTED THAT NEEDLES DETACHED. A NEW NEEDLE FROM ANOTHER COMPANY WAS TAKEN OUT, AND THE SUTURE ATTACHED TO THE PATIENT CONTINUED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496648 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE HEMORRHOIDECTOMY, WHEN CLOSING THE WOUND, THE NINE NEEDLES BENT. AFTER THE FIRING IS APPLIED TO THE TISSUE, THE NEEDLES WERE HELD WITH THE NEEDLE HOLDER AND THE THREAD WAS PULLED, THE NEEDLES BECAME MISALIGNED AFTER 3 TO 4 SUTURING. ADDITIONALLY, IT WAS NOTED THAT NEEDLES DETACHED. A NEW NEEDLE FROM ANOTHER COMPANY WAS TAKEN OUT, AND THE SUTURE ATTACHED TO THE PATIENT CONTINUED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496596 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE HEMORRHOIDECTOMY, WHEN CLOSING THE WOUND, THE NINE NEEDLES BENT. AFTER THE FIRING IS APPLIED TO THE TISSUE , THE NEEDLES WERE HELD WITH THE NEEDLE HOLDER AND THE THREAD WAS PULLED, THE NEEDLES BECAME MISALIGNED AFTER 3 TO 4 SUTURING. ADDITIONALLY, IT WAS NOTED THAT NEEDLES DETACHED. A NEW NEEDLE FROM ANOTHER COMPANY WAS TAKEN OUT, AND THE SUTURE ATTACHED TO THE PATIENT CONTINUED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496544 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE HEMORRHOIDECTOMY, WHEN CLOSING THE WOUND, THE NINE NEEDLES BENT. AFTER THE FIRING IS APPLIED TO THE TISSUE, THE NEEDLES WERE HELD WITH THE NEEDLE HOLDER AND THE THREAD WAS PULLED, THE NEEDLES BECAME MISALIGNED AFTER 3 TO 4 SUTURING. ADDITIONALLY, IT WAS NOTED THAT NEEDLES DETACHED. A NEW NEEDLE FROM ANOTHER COMPANY WAS TAKEN OUT, AND THE SUTURE ATTACHED TO THE PATIENT CONTINUED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496504 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, AT WOUND CLOSURE, THE 10 NEEDLES WERE BENT WHEN PULLED THE THREAD WHILE HOLDING IT WITH THE NEEDLE HOLDER. THE NEEDLES DETACHED FROM THE SUTURE THREAD AFTER ONLY ABOUT 3-4 STITCHES BUT DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390735 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, AT WOUND CLOSURE, THE 10 NEEDLES WERE BENT WHEN PULLED THE THREAD WHILE HOLDING IT WITH THE NEEDLE HOLDER. THE NEEDLES DETACHED FROM THE SUTURE THREAD AFTER ONLY ABOUT 3-4 STITCHES BUT DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390730 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, AT WOUND CLOSURE, THE 10 NEEDLES WERE BENT WHEN PULLED THE THREAD WHILE HOLDING IT WITH THE NEEDLE HOLDER. THE NEEDLES DETACHED FROM THE SUTURE THREAD AFTER ONLY ABOUT 3-4 STITCHES BUT DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390689 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, AT WOUND CLOSURE, THE 10 NEEDLES WERE BENT WHEN PULLED THE THREAD WHILE HOLDING IT WITH THE NEEDLE HOLDER. THE NEEDLES DETACHED FROM THE SUTURE THREAD AFTER ONLY ABOUT 3-4 STITCHES BUT DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390658 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, AT WOUND CLOSURE, THE 10 NEEDLES WERE BENT WHEN PULLED THE THREAD WHILE HOLDING IT WITH THE NEEDLE HOLDER. THE NEEDLES DETACHED FROM THE SUTURE THREAD AFTER ONLY ABOUT 3-4 STITCHES BUT DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390639 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, AT WOUND CLOSURE, THE 10 NEEDLES WERE BENT WHEN PULLED THE THREAD WHILE HOLDING IT WITH THE NEEDLE HOLDER. THE NEEDLES DETACHED FROM THE SUTURE THREAD AFTER ONLY ABOUT 3-4 STITCHES BUT DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390605 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, AT WOUND CLOSURE, THE 10 NEEDLES WERE BENT WHEN PULLED THE THREAD WHILE HOLDING IT WITH THE NEEDLE HOLDER. THE NEEDLES DETACHED FROM THE SUTURE THREAD AFTER ONLY ABOUT 3-4 STITCHES BUT DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390599 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, AT WOUND CLOSURE, THE 10 NEEDLES WERE BENT WHEN PULLED THE THREAD WHILE HOLDING IT WITH THE NEEDLE HOLDER. THE NEEDLES DETACHED FROM THE SUTURE THREAD AFTER ONLY ABOUT 3-4 STITCHES BUT DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390589 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, AT WOUND CLOSURE, THE 10 NEEDLES WERE BENT WHEN PULLED THE THREAD WHILE HOLDING IT WITH THE NEEDLE HOLDER. THE NEEDLES DETACHED FROM THE SUTURE THREAD AFTER ONLY ABOUT 3-4 STITCHES BUT DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390223 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, AT WOUND CLOSURE, THE 10 NEEDLES WERE BENT WHEN PULLED THE THREAD WHILE HOLDING IT WITH THE NEEDLE HOLDER. THE NEEDLES DETACHED FROM THE SUTURE THREAD AFTER ONLY ABOUT 3-4 STITCHES BUT DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390181 ↗
• MalfunctionJul 16, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE RECTAL PROLAPSE PROCEDURE, WHEN SUTURING THE ANUS, THE TWO NEEDLES WERE PHYSICALLY DISENGAGED INTO SEPARATE PIECES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757014 ↗
• MalfunctionJul 16, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE RECTAL PROLAPSE PROCEDURE, WHEN SUTURING THE ANUS, THE TWO NEEDLES WERE PHYSICALLY DISENGAGED INTO SEPARATE PIECES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756715 ↗